EDF Health

EU gets ready to ban most BPA uses. Once again: Where’s FDA?

By EDF Blogs / Published: March 1, 2024

By Maricel Maffini, PhD, Consultant, and Tom Neltner, Executive Director, Unleaded Kids

Warning message written in bold red letters with words Bisphenol A Exposure. 3d illustration.

What’s Happening?

On February 9, 2024, the European Commission published a proposed regulation [PDF, 502KB] that would ban most uses of bisphenol A (BPA) in materials that contact food—including plastic and coatings applied to metal cans—and restrict other uses. Interested parties can comment on the draft until March 8, 2024. (You must register to comment.)

This proposed regulation is based on the 2023 European Food Safety Authority’s (EFSA) risk assessment of BPA that concluded that dietary exposures are a health concern. The proposed regulation would impact the following bisphenol-based food contact materials:

  • Plastics: Would be banned from use if made from BPA at any stage of manufacturing.1 The only exception is polysulfone resins made from a sodium salt of BPA, which are allowed for use in filtration membranes if there is no detectable migration into food.
  • Varnishes, coatings, printing inks, adhesives, ion-exchange resins, and rubbers: Use of BPA and bisphenol S (BPS)2 would be banned at any stage of manufacture. Use of BPS or other bisphenols may be authorized on a case-by-case basis. The exception to the ban is bisphenol-A diglycidyl ether (BADGE)3 made from BPA and used to make epoxy-based varnishes and coatings, which are allowed only in making materials with capacity of more than 250 liters and there is no detectable migration4 into food.
  • Recycled materials: Unintentional BPA contamination would be allowed if there is no detectable migration into food.

Why It Matters

In its 2023 reassessment, EFSA estimated that the amount of BPA that could be safely consumed daily is 20,000 times less than its 2015 estimate. Among the health problems associated with BPA exposure are harm to the immune and reproductive systems, disruption of the normal function of hormones and reduced learning and memory.

The draft rule would manage the risk of BPA uses to significantly reduce dietary exposure after considering alternatives that are technically feasible at a commercial scale.

Our Take

The European Commission’s proposed rule is an excellent example of a risk management decision that considers safety and achievability. The Commission balanced protecting human health by eliminating as many sources of BPA as fast as possible with the implementation challenges. The Commission has included transition periods to eliminate all uses of food-contact articles manufactured with BPA ranging from 18 months for final food packaging (e.g., plastics, can coating) to 10 years for repeat-use, final food contact articles used in food production equipment.

In a previous blog, we stated that Americans’ exposure to BPA from food is similar to that of Europeans. Unfortunately, FDA doesn’t share the same sense of urgency as the European Commission. While Europe is on track to ban most uses of BPA in food contact materials, FDA is failing to take action to protect our families.

EDF and our allies submitted a food additive petition [PDF, 542KB] asking the agency to limit BPA exposure from food by revoking approvals for using BPA in adhesives and can coatings and to setting strict limits on using BPA in plastic that contacts food. FDA filed the petition on May 2, 2022, and has not made a final decision on it, despite a 180-day statutory deadline. It is now more than 600 days overdue.

Timeline

Once the rules are finalized, compliance would be required within 18 months for most products and within 36 months for:

  • Varnishes and coatings for processed fruit, vegetable, and processed fish products.
  • Varnishes and coatings used outside of metal packaging.
  • Manufacture of repeat-use components in professional food production equipment.

The rule would also allow repeat-use, final food contact articles used in professional food production equipment to remain in service for up to 10 years.

What’s Next?

We will submit comments to the European Commission seeking clarity on some aspects of the proposal. In addition, we will continue to press FDA to make a final decision on our petition, including potentially taking legal action for unreasonable delay in responding to it.

Go Deeper

Read our blogs on BPA.

NOTES

1 The rule is inconsistent regarding status of plastics other than polysulfone. EDF will submit comments seeking clarity.

2 The Commission may expand to more bisphenols if they are added to Annex VI, Part 3 of Regulation (EC) No 1272/2008 due to their harmonized classification as category 1A or 1B “mutagenic,” “carcinogenic,” “toxic to reproduction” or category 1 “endocrine disrupting” for human health.

3 BADGE (CAS No 1675-54-3) – is a type of epoxy resin manufactured from BPA.

4 Rule defines the limit of detection as 0.01 milligram of bisphenol per kilogram of food.

Posted in BPA, EFSA, FDA / Tagged , , | Authors: / Comments are closed

FDA’s latest study reaffirms short-chain PFAS biopersist. Now it must act.

By EDF Blogs / Published: January 25, 2024

By Maricel Maffini, PhD, Consultant, and Tom Neltner, JD

Female rat nursing multiple pups

FDA study found biopersistent PFAS in female rats and their pups,

What Happened

In December 2023, FDA’s scientists published a new study showing that when pregnant rats ingest a form of per- and polyfluorinated alkyl substance (PFAS) called 6:2 fluorotelomer alcohol (6:2 FTOH) their bodies break it down into other PFAS that reach the fetuses and biopersist in the mother and the pups.

The study also showed that the body of a non-pregnant animal produces different breakdown products that also biopersist. This study is the latest evidence that the assumptions made about the safety of short-chain PFAS (chemicals with fewer than 8 carbons) have been wrong. Read More »

Posted in Adverse health effects, Chemical regulation, Emerging science, FDA, Health science, Industry influence, PFAS, Public health, Rules/Regulations, Vulnerable populations / Tagged , , , , , , , | Authors: / Comments are closed

California mandates toxics testing/disclosure for baby food

By EDF Blogs / Published: October 11, 2023

Tom Neltner, Senior Director, Safer Chemicals and Katelyn Roedner Sutter, State Director, California

Three jars of baby food surrounded by cut-up vegetables and fruit

What Happened?

On October 10, 2023, California Assembly Bill 899, authored by Assembly Member Al Muratsuchi, became law. It requires manufacturers of baby food (other than infant formula) who wish to sell their products in California to:

  • Test a representative sample of each baby food product for four toxic elements (arsenic, cadmium, lead, and mercury) at least monthly starting in 2024.
  • Provide the test results to the California Department of Health upon request.
  • Make the results of the testing publicly available on the manufacturer’s website for the shelf life of the product plus one month. That provision goes into effect in 2025.

In addition, as FDA establishes action levels for the four toxic elements, manufacturers must also include a quick response (QR) code on the label that links to the manufacturer’s website, where consumers can find the test results for that toxic element.

Why It Matters

By requiring testing and reporting on these foods, California will provide parents and guardians with important information they need to compare products and make purchasing decisions. The law also:

  • Sets a precedent for greater testing and disclosure of food contaminants; and,
  • Is noteworthy, in that baby food companies did not oppose the bill.

The law will strengthen FDA’s efforts to reduce children’s dietary exposure to those toxic elements to the lowest possible levels, while maintaining access to nutritious foods by filling two critical gaps in FDA’s Closer to Zero program. FDA current approach sets action levels on final products that food companies must meet and requires they use preventive controls to manage toxic elements in their ingredients. It does not require final product testing or disclosure of any testing results.

Read More »

Posted in FDA, Food, Health policy, Markets and Retail / Tagged , , , , , | Authors: / Comments are closed

Broken GRAS: Companies ignore FDA draft guidance; Bias & conflicts of interest prevail in safety determinations

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: September 6, 2023

By Tom Neltner, Senior Director, Safer Chemicals, Klara Matouskova, PhD, Consultant, and Maricel Maffini, PhD, Consultant

What Happened?

In our new study, we evaluated Generally Recognized As Safe (GRAS) notices—a total of 403 between 2015-2020—that food manufacturers voluntarily submitted to FDA for review. Our goal was to determine whether industry was adhering to FDA’s Guidance on Best Practices for Convening a GRAS Panel.

The guidance was designed to help companies comply with the law and avoid biases and conflicts of interest when determining whether substances added to food are safe and recognized as such by the scientific community. FDA published a draft of the guidance in 2017 and finalized it essentially unchanged in December 2022.Infographic showing how a small group of individuals populate almost half of GRAS review panels. Seven individuals accounted for 46 percent of available panel positions.

Our study found that no GRAS notices followed the draft guidance. Specifically, we also found there were high risks of bias and conflicts of interest because the companies:

  • Had a role—either directly or through a hired third party—in
    selecting panelists that likely resulted in bias and conflicts of interest.
  • Depended on a small pool of experts in which seven individuals occupied 46% of panel positions. The seven often served together, further enhancing risk of bias.
  • Relied on panels that did not realistically reflect the diverse scientific community that evaluates chemical risks to public health—which is needed to comply with the law’s requirement that there be a “general recognition” within that community that a substance is GRAS.

Read More »

Posted in Broken GRAS, Conflict of interest, FDA, Food, GRAS, Industry influence / Tagged , , | Authors: / Comments are closed

Is it time to rethink “lead-safe” and “lead-free”?

By Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 30, 2023

By Tom Neltner, Senior Director, Safer Chemicals Initiative, Environmental Defense Fund and Charlotte Brody, National Director, Healthy Babies Bright Futures

Key Message

The scientific consensus is that there is no known safe level of lead exposure, and that no environment or home is truly free of lead.

With a few exceptions, we think it is time to retire the terms “lead-safe” and “lead-free” from our vocabulary. It sends conflicting messages to the public, consumers, and decision-makers. And it may undermine our efforts to reduce children’s exposure to lead from any source.

Rationale

Collectively, we have dedicated over a half-century to protecting children from lead. During that time, we and other advocates have used different terms to communicate our goals. Often, we drew our terms from the federal government. For example:

  • “Lead-free” has been used by Congress since 1986 to define drinking water pipes with no more than 80,000 parts per million (ppm) of lead. It kept the term in 2014 when it changed the level from 80,000 to 2,500 ppm. Similarly, FDA issued guidance in 2010 allowing a “lead-free” label on pottery if it meets the agency’s limits on lead.
  • “Lead-safe” is in the title for HUD’s 1999 rule to reduce lead-based paint exposure in federally assisted EPA also refers to “lead-safe work practices” in its 2008 renovation, repair and painting (RRP) rule for residential property. In addition, EPA created a “lead-safe” logo in 2010 for certified RRP firms. And HUD, EPA, and CPSC use the term in their pamphlet given to millions of families renting or buying homes built before 1978.

As a result, terms like “lead-safe” and “lead-free” have been commonly used to describe community-wide initiatives, label houses on maps, describe the state of a house after remediation, and much more.

What does lead-free mean? It depends on who you’re asking and what you’re asking about. A contractor may understand the term to mean that a house meets the EPA definition of not having a lead hazard, but does the average resident understand the term the same way? Is it accurate to describe a house as lead-free if there is still lead in the drinking water? Or in the spices in the cabinets?

Read More »

Posted in Contamination, FDA, Lead, Public health, Unleaded Juice / Tagged , , , , | Authors: / Read 2 Responses

FDA’s squishy definition of adverse health effects of substances in food

By Maricel Maffini, PhD, Consultant and Tom Neltner, Senior Director, Safer Chemicals Initiative / Published: June 15, 2023

Maricel Maffini, consultant, and Tom Neltner, Senior Director, Safer Chemicals

3 human figures showing stages of becoming ill. First figure is all white and standing up straight. Second figure is bent over and stomach area is red. Third figure is is all red, bent over, and appears to be vomiting.

What Happened

A recent peer-reviewed publication criticized FDA’s criteria for identifying adverse health effects associated with exposure to pathogens, chemicals, or allergens in foods. The authors gave two recent examples of the agency dismissing health concerns: a toxin created in spoiled fish that caused temporary, medically adverse health effects because they were short-term and reversible, and an additive where evidence from animal testing showed harm in only one sex. The authors concluded that the agency’s criteria are “inadequate because they are not science-based.”

Why It Matters

FDA is responsible for protecting food safety and the public’s health. In order to do that, it makes decisions whether a pathogen, chemical, or allergen causes an adverse health effect that must be avoided—so the agency’s definition of an adverse health effect is critically important. Unfortunately, FDA lacks a clear definition of the term, usually approaching it on a case-by-case basis in a manner that lacks transparency and scientific grounding.

Adverse Effects Dismissed by FDA

In 2020, the director of The Pew Charitable Trusts’ food safety project argued that FDA failed to “protect Americans from preventable illnesses” because it considered that the effects caused by the fish toxin were temporary or reversible. FDA described the toxin’s effects, which ranged from facial flushing and sweating, dizziness, nausea and headache to more severe cases of blurred vision, respiratory stress, and swelling of the tongue. The Pew director reasonably added that people may require hospitalization, medical treatment due to cardiac complications, and altered blood pressure–all of which are adverse health effects.

In a 2019 final rule approving the listing of leghemoglobin as a color additive, the Center for Food Safety objected that FDA dismissed statistically significant “changes in blood chemistry, blood clotting ability, and blood globulin values” as potential health effects. In its response to the objection, the agency argued that “statistical differences seen between control animals and treatment animals due to small changes in the value of the parameter are not likely to be of biological or toxicological significance.” FDA further stated that for the color additive to cause the blood changes to be “potentially adverse” it should:

  • Show a “clear dose-response,” described as a direct relationship between the dose given and the effect observed, in other words, the higher the dose, the higher the effect; and
  • Be observed in both sexes of the species in which the substance is tested.

This argument put forth by FDA’s food safety scientists would be summarily dismissed by their colleagues on the drug side because it ignores current scientific principles: dose responses can have different shapes and there are known sex differences in response to exposures from multiple chemicals.

Our Take

This is an ongoing issue. Other organizations have defined “adverse health effects.” For example, EPA’s Integrated Risk Information System (IRIS) defines adverse effect as “[a] biochemical change, functional impairment, or pathologic lesion that affects the performance of the whole organism, or reduces an organism’s ability to respond to an additional environmental challenge.”

FDA’s lack of a practical definition for adverse health effect and how the agency applies it in food safety assessments has likely contributed to inconsistencies in its decision making.

Next Steps

We will continue to press the agency for transparency about what health effects it considers important to prevent and protect the health of American families. FDA should publish clear, rational, science-based criteria for determining adverse effects and periodically review them as our knowledge base advances to better inform regulatory decisions.

Posted in Adverse health effects, FDA, Health hazards, Health policy, Health science, Public health, Regulation / Tagged , , , | Authors: , / Comments are closed